More about this trial

Chemotherapy and a drug called rituximab are the usual treatments for DLBCL. This works well for many people and gets rid of the lymphoma cells (gets it into remission). But sometimes, the DLBCL doesn’t go away, or it comes back after a short period.

So some people might then have high dose chemotherapy followed by a stem cell transplant. But this isn’t suitable for everyone. So doctors are trying to improve treatment for this group of people.

In this study, they are looking at a new combination of treatments. It includes:

These are all types of targeted cancer drugs that work in different ways. This study is the first time people with DLBCL are having these 3 drugs together. This study has been ongoing for more than 3 years.

The study is in 2 parts. The first part is complete. It looked at the best dose of treatment. The 2nd part is now open and it is looking at treatment in a larger group of people.

The aims of the study are to:

find out how well the treatment works

learn more about the side effects

find out what happens to the drugs in the body

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this study if all of the following apply.

You:

have diffuse B cell lymphoma that came back after your last treatment or the last treatment you had stopped working

have a sample of the lymphoma available for the study team to do some tests

have a sub type of DLBCL called non GCB

had a suitable first treatment for the lymphoma such as chemotherapy and rituximab (R-CHOP)

had an abnormal scan result and if the doctors were uncertain that the lymphoma had come back, you gave a tissue sample to confirm it had

haven’t had high dose chemotherapy and a stem cell transplant and this was because any of the following apply:

oyou are 70 years or older

oyou have problems with your heart or lungs

oyou have severe problems with other organs in the body

oyou don’t want this treatment

otreatment hasn’t worked so far

have lymphoma that can be measured on a scan and measures more than 1.5 cm across

have problems with your heart, such as a heart attack in the last 6 months, high blood pressure that is not well controlled, angina that is not well controlled, an abnormal rhythm of your heart, congestive heart failure or decreased blood flow to the arteries in the heart

have any other serious medical condition or mental health problem that the study team think could affect you while taking part in the study

Other

You:

are sensitive to lenalidomide, thalidomide or rituximab

are pregnant or breastfeeding

Trial design

This is a phase 1/2 study. The study is in 2 parts. In part 1 the researchers looked at the best dose of lenalidomide to give alongside standard doses of ibrutinib and rituximab. They have found this dose and this part of the study is now closed.

You have rituximab as a drip into a vein, once every 4 weeks. It takes between 3 and 6 hours each time. You have up to 6 cycles of rituximab treatment.

Ibrutinib is a capsule. You take them once a day, every day.

Lenalidomide is a capsule. You take them once a day for 21 days followed by 7 days when you don’t take any lenalidomide.

You take your capsules at home. The study team will give you a fresh supply at the beginning of each treatment cycle.

You continue taking ibrutinib and lenalidomide for as long as the study doctor and staff feel it is in your best interest to continue the study. The study doctor will check how the treatment is working and the side effects you may have to help make this decision.

Samples for research

You give some extra blood samples during treatment. You give the samples at specific times and the study team will give you more information about this. They plan to use the samples to:

see how well the treatment is working

find what happens to the drugs in the body

look at genes to help understand more about DLBCL

look for biomarkers to predict who will benefit from treatment

The doctors will ask permission to collect and store some of your blood and a sample of the lymphoma (tissue sample). This is for future research. Researchers will use them to understand more about this treatment and how it works.

You do not have to agree to give these samples if you don’t want to. You can still take part in the study.

Hospital visits

You see a doctor and have some tests before you start treatment. The tests include:

You have rituximab in the outpatient department. You shouldn’t need to stay overnight.

You go to the hospital:

once a week for the first month

twice a month for the next 2 months

once a month after that

At each visit, you see the study doctor for a check up and blood tests. You have a CT or PET scan every 3 months.

You stop treatment if the lymphoma gets worse. You see the study doctor for a check up a month later. Your doctor will discuss other treatment options with you. The study nurse will contact you at home every 3 months to see how you are getting on.

You see the study doctor and have a CT scan every 3 months if you stopped treatment but the lymphoma hasn’t got worse. You then continue to have check ups until either the lymphoma gets worse or you start another anti- cancer treatment.

Side effects

Having lenalidomide, ibrutinib and rituximab together is a new treatment combination. So there might be side effects we don’t know about yet. The study team will monitor you during the time you have treatment and you’ll have a number to call if you are worried about anything.

changes in sense of touch or pain, numbness and tingling in your hands and feet (peripheral neuropathy)

shaking (tremor)

feeling sad (depression)

blood clot in the legs, lungs and other organs

high blood sugar

The most common side effects of rituximab include:

infections

joint and muscle pain

tummy pain

tiredness (fatigue)

a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness

runny nose (rhinitis)

feeling or being sick

low blood pressure

diarrhoea

There is a small chance you might have an allergic reaction to the drug during the infusion, causing flu like symptoms such as a fever, chills and shivering (rigors). You might also have a headache and feel sick. Your nurse will give you medicines beforehand to try to prevent a reaction. They will keep a close eye on you and treat any problems straight away.

Recruitment start:

01/02/2014

Recruitment end:

30/09/2018

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

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